The Food and Drug Administration (FDA) today announced a broader import control of all farm-raised catfish, basa, shrimp, dace (related to carp), and eel from China. FDA will start to detain these products at the border until the shipments are proven to be free of residues from drugs that are not approved in the United States for use in farm-raised aquatic animals.

This action by FDA, a part of the U.S. Department of Health and Human Services, will protect American consumers from unsafe residues that have been detected in these products. There have been no reports of illnesses to date.

"We're taking this strong step because of current and continuing evidence that certain Chinese aquaculture products imported into the United States contain illegal substances that are not permitted in seafood sold in the United States," said Dr. David Acheson, FDA's assistant commissioner for food protection. "We will accept entries of these products from Chinese firms that demonstrate compliance with our requirements and safety standards."

During targeted sampling from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood imported from China were contaminated with antimicrobial agents that are not approved for this use in the United States.

The contaminants were the antimicrobials nitrofuran, malachite green, gentian violet, and fluoroquinolone. Nitrofuran, malachite green, and gentian violet have been shown to be carcinogenic with long-term exposure in lab animals. The use of fluoroquinolones in food animals may increase antibiotic resistance to this critically important class of antibiotics.

None of these substances is approved for use in farm-raised seafood in the United States, and the use of nitrofurans and malachite green in aquaculture is also prohibited by Chinese authorities. Chinese officials have acknowledged that fluoroquinolones are used in Chinese aquaculture and are permitted for use in China.

The levels of the drug residues that have been found in seafood are very low, most often at or near the minimum level of detection. FDA is not seeking recall of products already in U.S. commerce and is not advising consumers to destroy or return imported farm-raised seafood they may already have in their homes. FDA is concerned about long term exposure as well as the possible development of antibiotic resistance.

The FDA action includes conditions under which an exporter can be exempted from FDA's detention action by providing specified information to the agency. This information must demonstrate the exporter has implemented steps to ensure its products do not contain these substances and that preventive controls are in place. The additional import controls placed on seafood from China will last as long as needed.

FDA may allow the entry into the United States and subsequent distribution into the marketplace of individual shipments of the Chinese farm-raised seafood products if the company provides documentation to confirm the products are free of residues of these drugs.